Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brown University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks
Overview
Brief Summary
The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care.
The purpose of the proposed project is to establish the efficacy of ABBT and examine its mechanisms of action. To achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: ABBT vs. an attention-matched HIV education control condition.
Detailed Description
Drop-out rates from medical clinics in the first months following linkage to HIV care are as high as 50%, with 31-46% of patients dropping out after the first visit. People Living with HIV (PLWH) who are not consistently retained in care are at risk for: delayed antiretroviral treatment (ART) initiation, reduced ART adherence, unsuppressed viremia, and mortality. Moreover, poor retention means effective ART cannot be leveraged to prevent further HIV transmission. The objective of this study is to conduct a fully powered, randomized controlled trial (RCT) to assess the efficacy of a brief, 2-session acceptance-based behavioral therapy (ABBT) intervention to enhance retention in HIV care.
The aims of this proposal are: (1) To test, in a 2-arm RCT, the efficacy of the ABBT intervention on retention in care and virologic suppression (primary outcomes); and, ART adherence, disclosure of HIV status, perceived social support, HIV stigmatization (secondary outcomes), relative to an Enhanced-Treatment-as-Usual condition; and, (2) To examine the degree to which retention in HIV care and virologic suppression are mediated by (a) increased HIV acceptance (and decreased HIV experiential avoidance) and (b) increased willingness to disclose HIV status. The sample will consist of 270 HIV patients who are new to care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years old
- •Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)
- •Able to speak and read English at the level to be able to complete the study procedures
- •Have telephone access.
Exclusion Criteria
- •1\. Cognitively impaired
Outcomes
Primary Outcomes
Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks
Time Frame: 52 weeks
Objective data from participants' electronic health records will be obtained to examine how many medical appointments they attended in the past year at their HIV treatment clinic. Participants will be deemed as sufficiently retained if they attend at least 3 medical visits during this period.
Number of Participants Who Met HIV Virologic Suppression
Time Frame: 52 weeks
Objective data from participants' electronic health records will be obtained to examine their viral load, which is a blood-based measure of the amount of HIV viruses in the person's body. If participants are not currently retained in medical care and blood sample results are not available in their electronic health record, they will submit 1-3ml of blood at each assessment through the study's research phlebotomist. A viral load that measures as "undetectable" (i.e., fewer than 200 copies of HIV per millilitre of blood) will represent virologic suppression, which is a positive indication of HIV health.
Secondary Outcomes
- Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence(52 weeks)
- Brief HIV Disclosure Scale (BHD)(52 weeks)
- The Multidimensional Scale of Perceived Social Support (MSPSS)(52 weeks)
- HIV Stigma Scale (HSS)(52 weeks)